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| Name | Class |
|---|---|
| Sanofi-Synthelabo | INDUSTRY |
| Aventis Pharmaceuticals | INDUSTRY |
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In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the 3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the 3-drug combination is considered too toxic, the phase II study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.
Upon determination of eligibility, patients will be receive:
Oxaliplatin + Docetaxel + Capecitabine + Radiation therapy
If the three-drug chemotherapy regimen, with radiation therapy, is tolerable, this regimen will be taken forward into the phase II portion of the trial. If the three-drug regimen is too toxic, the phase II portion will proceed with the two-drug regimen Oxaliplatin + Docetaxel + Radiation therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions). Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved. |
|
| Cohort 2 | Experimental | Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions). Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin | Drug | 40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery | The absence of any residual tumor cells in a histologic evaluation of a tumor specimen following surgery is defined as a complete pathologic response | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival (DFS) | Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause. | 18 months |
| Overall Survival (OS) |
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Inclusion Criteria:
To be included in this study, you must meet the following criteria:
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
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| Name | Affiliation | Role |
|---|---|---|
| David R. Spigel, MD | SCRI Development Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tower Oncology | Beverly Hills | California | 90211 | United States | ||
| Integrated Community Oncology Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20351330 | Result | Spigel DR, Greco FA, Meluch AA, Lane CM, Farley C, Gray JR, Clark BL, Burris HA 3rd, Hainsworth JD. Phase I/II trial of preoperative oxaliplatin, docetaxel, and capecitabine with concurrent radiation therapy in localized carcinoma of the esophagus or gastroesophageal junction. J Clin Oncol. 2010 May 1;28(13):2213-9. doi: 10.1200/JCO.2009.24.8773. Epub 2010 Mar 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxaliplatin/Docetaxel/Radiation (Cohort 1) | oxaliplatin, docetaxel and radiation therapy Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began. |
| FG001 | Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Docetaxel | Drug | 20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts |
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| Capecitabine | Drug | In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. |
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| Radiation therapy | Radiation | In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions). |
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Length of time, in months, that patients were alive from their first date of protocol treatment until death.
| 36 months |
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Atlanta Cancer Care | Atlanta | Georgia | 30342 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Wellstar Cancer Research | Marietta | Georgia | 30060 | United States |
| Consultants in Blood Disorders and Cancer | Louisville | Kentucky | 40207 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
Oxaliplatin, docetaxel, capecitabine, and radiation therapy. Ten patients were enrolled in phase I cohort 2; an additional 39 patients were subsequently enrolled in the phase II portion and treated with the phase I cohort 2 regimen. Data from all 49 patients receiving the cohort 2 regimen was analyzed and reported. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxaliplatin/Docetaxel/Radiation (Cohort 1) | oxaliplatin, docetaxel and radiation therapy Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began. |
| BG001 | Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2) | Oxaliplatin, docetaxel, capecitabine, and radiation therapy. Ten patients were enrolled in phase I cohort 2; an additional 39 patients were subsequently enrolled in the phase II portion and treated with the phase I cohort 2 regimen. Data from all 49 patients receiving the cohort 2 regimen was analyzed and reported. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery | The absence of any residual tumor cells in a histologic evaluation of a tumor specimen following surgery is defined as a complete pathologic response | Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy | Posted | Count of Participants | Participants | 18 months |
|
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| Secondary | Disease-Free Survival (DFS) | Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause. | Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy | Posted | Median | 95% Confidence Interval | months | 18 months |
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| Secondary | Overall Survival (OS) | Length of time, in months, that patients were alive from their first date of protocol treatment until death. | Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy | Posted | Median | 95% Confidence Interval | months | 36 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxaliplatin/Docetaxel/Radiation (Cohort 1) | Oxaliplatin, docetaxel, and radiation therapy. Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began. | 2 | 10 | 10 | 10 | ||
| EG001 | Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2) | Oxaliplatin, docetaxel, capecitabine, and radiation therapy. Ten patients were enrolled in phase I cohort 2; an additional 39 patients were subsequently enrolled in the phase II portion and treated with the phase I cohort 2 regimen. Data from all 49 patients receiving the cohort 2 regimen was analyzed and reported. | 33 | 49 | 49 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| ARDS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Respiratary - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Pneumoperitoneum |
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| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Perforation, GI | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fistula, GI | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Abdomen | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stricture, GI | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/Thrombus/Embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GI - Other | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Hematemesis |
|
| Pain - Back | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| CNS Ischemia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GI - Other | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Paraesophageal hernia |
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| Infection - Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Adult Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - joint | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Cold intolerance | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - abdomen | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - chest | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fistula - esophagus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hiccoughs | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Voice changes | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema NOS | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disorder | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - throat | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
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The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Hainsworth, MD | Sarah Cannon Research Institute | 1-877-691-7274 | asksarah@scresearch.net |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000077143 | Docetaxel |
| D000069287 | Capecitabine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013812 | Therapeutics |
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| Male |
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